Tretinoin and the prevention of keratinocyte carcinoma (basal and squamous cell carcinoma of the skin): A veterans affairs randomized chemoprevention trial

Martin A. Weinstock, Stephen F. Bingham, John J. Digiovanna, Amilcar E. Rizzo, Kim Marcolivio, Russell Hall, David Eilers, Mark Naylor, Robert Kirsner, James Kalivas, Gary Cole, Julia E. Vertrees

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66 Scopus citations

Abstract

Keratinocyte carcinoma (KC) is the most common cancer in the United States, with no proven means for prevention other than systemic retinoids, which have significant toxicity, and sunscreen. Topical tretinoin has been used for KC chemoprevention, although this use is unproven. Hence, we conducted the randomized Veterans Affairs Topical Tretinoin Chemoprevention Trial of high-dose topical tretinoin for KC prevention. We randomized 1,131 patients to topical 0.1% tretinoin or a matching vehicle control for 1.5-5.5 years. The primary outcomes were time to development of new basal cell carcinoma (BCC) and new invasive squamous cell carcinoma (SCC) on the face or ears. The effects were not significant (P0.3 for BCC and P0.4 for SCC). The proportions of the tretinoin and control groups who developed a BCC at 5 years were 53 and 54% and an invasive SCC at 5 years were 28 and 31%. These differences (95% confidence intervals) were: for BCC, 1.0% (6.5, 8.6%); for SCC, 3.6% (3.1, 10.3%). No differences were observed in any cancer-related end points or in actinic keratosis counts. The only quality of life difference was worse symptoms in the tretinoin group at 12 months after randomization. This trial in high-risk patients demonstrates that high-dose topical tretinoin is ineffective at reducing risk of KCs.

Original languageEnglish (US)
Pages (from-to)1583-1590
Number of pages8
JournalJournal of Investigative Dermatology
Volume132
Issue number6
DOIs
StatePublished - Jun 2012
Externally publishedYes

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ASJC Scopus subject areas

  • Dermatology
  • Biochemistry
  • Cell Biology
  • Molecular Biology

Cite this

Weinstock, M. A., Bingham, S. F., Digiovanna, J. J., Rizzo, A. E., Marcolivio, K., Hall, R., Eilers, D., Naylor, M., Kirsner, R., Kalivas, J., Cole, G., & Vertrees, J. E. (2012). Tretinoin and the prevention of keratinocyte carcinoma (basal and squamous cell carcinoma of the skin): A veterans affairs randomized chemoprevention trial. Journal of Investigative Dermatology, 132(6), 1583-1590. https://doi.org/10.1038/jid.2011.483